Basic BBIBP-CorV Vaccination is Not as Effective as BNT162bNCT05547802
Serology After BBIBP-CorV Inactivated Vaccine Combined With BNT62b2 mRNA Booster Vaccine
An observational study of Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b, run by University of Debrecen at 1 site in Hungary.
Trial summary
In this prospective study, SARS-CoV-2 spike protein specific total immunoglobulin (Ig) levels are analyzed before and after BNT162b2 third mRNA booster vaccination in individuals previously administered with two doses of BBIBP-CorV vaccine in comparison to immunized participants with three doses of BNT162b2… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b
- What is being tested?
- BBIBP-CorV and/or BNT162b2 vaccine
- Type of treatment
- Vaccines
- How many people
- 122 participants
- Where
- 1 siteHungary
- Study dates
- 16 Nov 2021to 28 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As part of the regular clinical practice, all participants received the third vaccine dose at a general practitioner's (GP) office. Following the initial immunization period, a survey was conducted to monitor vaccine efficacy via the incidence of infection and hospitalization by patient questionnaire. Booster immunization was carried out at least 4 months after the first two doses of basic immunization (two doses of BNT162b2 or BBIBP-CorV), and baseline (pre-booster) antibody level was measured on the same day of the administration of booster immunization (first sampling). Following the booster dose with BNT162b2, another serum sample was collected after 30 days in order to determine induced total level of anti-SARS-CoV-2 spike protein antibodies (second sampling).
Who may be able to join
- Exclusion Criteria: included age < 18 years, known primary immunodeficiency, malignancy and ongoing immunosuppressive therapy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of BBIBP-CorV Inactivated Vaccine Combined With BNT62b2 mRNA Booster Vaccine
In this prospective study, SARS-CoV-2 spike protein specific total immunoglobulin (Ig) levels are analyzed before and after BNT162b2 third mRNA booster vaccination in individuals previously administered with two doses of BBIBP-CorV vaccine in comparison to immunized participants with three doses of BNT162b2 vaccination. Questionnaires from recruited participants are reviewed prior to booster vaccination for the occurrence of a previous SARS-CoV-2 infection and hospitalization.
Read the detailed description
Sixty-one volunteers (39 females, 22 males) vaccinated by BBIBP-CorV were included with the mean age of 63.9 years. To serve as a control group, 61 patients (41 females, 20 males) were vaccinated with BNT162b2 at a mean age of 59.9 years. At least four months after the first two-dose vaccination regimens, both groups received the third booster BNT162b2 vaccine based on the recommendations of the Hungarian Public Health Centre. Total Ig levels against SARS-CoV-2 spike protein 1 receptor-binding domain (anti-SARS-CoV-2 S1-RBD) were measured by an immunoassay (Roche Diagnostics) and their calculated ratios after/before booster dose were compared between the two groups. Vaccination efficacy via incidence of infection and hospitalization was monitored during study period. We found that BNT162b2 can successfully booster the effect of two-dose BBIBP-CorV vaccination to enhance humoral immune response against SARS-CoV-2 infection.
- Being tested
- BBIBP-CorV and/or BNT162b2 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBIBP-CorV and/or BNT162b2 vaccineBiological
Booster immunization was carried out at least 4 months after the first two doses of basic immunization.
| Study group | Role | What they receive |
|---|---|---|
| Heterologous vaccination cohort | Subjects with two doses of BBIBP-CorV vaccine and third (second booster) dose of the BNT162b2 vaccine. Receives: Biological: BBIBP-CorV and/or BNT162b2 vaccine | |
| Homologous vaccination cohort | Subjects receiving three doses of BNT162b2 vaccine. Receives: Biological: BBIBP-CorV and/or BNT162b2 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serology status after booster vaccination
Following the booster dose, serum sample was collected after 30 days to determine induced total level of anti-SARS-CoV-2 spike protein antibodies.
Measured: 30 days
Secondary outcomes (1)
Development of COVID-19 disease
Vaccination efficacy via incidence of infection and hospitalization was monitored during study period.
Measured: Half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start16 Nov 2021
- Primary completion6 Jan 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basic BBIBP-CorV Vaccination is Not as Effective as BNT162bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Debrecen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Béla Nagy Jr., MD, PhD, University of Debrecen
- Investigators
- Zoltán Szekanecz, MD, PhD, Study director, University of Debrecen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547802
- Sponsor's protocol ID
- UDebrecen
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: These data will be published in a manuscript in a peer-reviewed international journal.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of BBIBP-CorV Inactivated Vaccine Combined With BNT62b2 mRNA Booster Vaccine
- ClinicalTrials.gov ID
- NCT05547802
- Acronym / sponsor ID
- UDebrecen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of DebrecenUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective study, SARS-CoV-2 spike protein specific total immunoglobulin (Ig) levels are analyzed before and after BNT162b2 third mRNA booster vaccination in individuals previously administered with two doses of BBIBP-CorV vaccine in comparison to immunized participants with three doses of BNT162b2 vaccination. Questionnaires from recruited participants are reviewed prior to booster vaccination for the occurrence of a previous SARS-CoV-2 infection and hospitalization.
Detailed description
Sixty-one volunteers (39 females, 22 males) vaccinated by BBIBP-CorV were included with the mean age of 63.9 years. To serve as a control group, 61 patients (41 females, 20 males) were vaccinated with BNT162b2 at a mean age of 59.9 years. At least four months after the first two-dose vaccination regimens, both groups received the third booster BNT162b2 vaccine based on the recommendations of the Hungarian Public Health Centre. Total Ig levels against SARS-CoV-2 spike protein 1 receptor-binding domain (anti-SARS-CoV-2 S1-RBD) were measured by an immunoassay (Roche Diagnostics) and their calculated ratios after/before booster dose were compared between the two groups. Vaccination efficacy via incidence of infection and hospitalization was monitored during study period. We found that BNT162b2 can successfully booster the effect of two-dose BBIBP-CorV vaccination to enhance humoral immune response against SARS-CoV-2 infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heterologous vaccination cohort | – | Biological: BBIBP-CorV and/or BNT162b2 vaccineSubjects with two doses of BBIBP-CorV vaccine and third (second booster) dose of the BNT162b2 vaccine. |
| Homologous vaccination cohort | – | Biological: BBIBP-CorV and/or BNT162b2 vaccineSubjects receiving three doses of BNT162b2 vaccine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As part of the regular clinical practice, all participants received the third vaccine dose at a general practitioner's (GP) office. Following the initial immunization period, a survey was conducted to monitor vaccine efficacy via the incidence of infection and hospitalization by patient questionnaire. Booster immunization was carried out at least 4 months after the first two doses of basic immunization (two doses of BNT162b2 or BBIBP-CorV), and baseline (pre-booster) antibody level was measured on the same day of the administration of booster immunization (first sampling). Following the booster dose with BNT162b2, another serum sample was collected after 30 days in order to determine induced total level of anti-SARS-CoV-2 spike protein antibodies (second sampling).
Key inclusion criteria (1 listed)
- Exclusion Criteria: included age < 18 years, known primary immunodeficiency, malignancy and ongoing immunosuppressive therapy.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBIBP-CorV and/or BNT162b2 vaccineBooster immunization was carried out at least 4 months after the first two doses of basic immunization. | Biological | Heterologous vaccination cohort, Homologous vaccination cohort |
Primary outcome
Serology status after booster vaccination
Time frame: 30 days
Following the booster dose, serum sample was collected after 30 days to determine induced total level of anti-SARS-CoV-2 spike protein antibodies.
1 secondary outcome
Development of COVID-19 disease
Time frame: Half year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No. These data will be published in a manuscript in a peer-reviewed international journal.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoltán Szekanecz, MD, PhD study director
University of Debrecen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b, run by University of Debrecen at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serology status after booster vaccination (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.